Agency begins its promised rewrite after a massive grassroots letter-writing campaign.
Last week ANH-USA, together with a number of supplement industry trade associations, met with the US Food and Drug Administration to discuss their promised revision of the FDA’s draft guidance for New Dietary Ingredients (NDIs) which, in ordinary English, means dietary supplements developed since 1994.
As you know, the guidance was originally released in July of 2011, and immediately faced a firestorm of criticism from consumers, natural health advocates, the supplement industry, and Congress. FDA took what was supposed to be a notification process for new supplements and turned it into a de facto pre-market approval system with so many absurd restrictions and arbitrary rules that it would have forced a large number of products off the market, denying you access. It would also have resulted in over $1 billion of lost industry revenue, and cost over 100,000 Americans their jobs now—and far more jobs in the future.
In June, after a massive grassroots letter-writing campaign, congressional leaders persuaded FDA to withdraw the guidance and start over—a startling reversal from the agency’s previous intransigence on the subject. Last Tuesday’s meeting was constructive—and significant in that it was the first time a group representing natural health and consumer activists had been invited to be at the table.
One main focus of the meeting was how the FDA would distinguish between old dietary ingredients (ODIs) and new ones. At issue is whether the FDA will agree with the supplement industry and the natural health community that many of the supplements used by consumers today should be considered ODIs and thus not subject to the new onerous regulations (currently being re-written) that threaten access to supplements.
This is a concern for consumers for many reasons. To take just one example, when a supplement is considered an NDI, drug companies, under some circumstances, are able to develop synthetic version of natural ingredients and then petition the FDA to remove the nutritional supplement versions of the ingredient from the market. This is what happened with pyridoxamine, one of the most bioavailable and best natural forms of vitamin B6—the supplement industry thought it was a grandfathered ODI and didn’t file an NDI notification, but the FDA ruled that it was an NDI. Now the natural supplement form of pyridoxamine is no longer available.
A second issue discussed was the creation of an official list of grandfathered ingredients, which currently does not exist. Should such a list be created? The concern is that FDA may determine that the list is static and any ingredient not on the list is by default an NDI. We don’t want the list to be used as a hammer by the FDA to go after industry and ultimately deny consumers access to safe supplements.
Then there’s the “chemically altered” question. Supplements that have been chemically altered, even if they were originally marketed before DSHEA was passed, become NDIs. But FDA’s definition of “chemically altered” is very broad. It may include a change in the manufacturing process—and there have been many such changes in the past eighteen years!
Many of these manufacturing processes do not chemically alter a supplement, just make it safer and better by taking advantage of new technologies. Since the purpose of the NDI notification process is to ensure safety, FDA shouldn’t freeze-frame the technology to 1994, but should instead allow for improvements—all the more so since the FDA is issuing guidance eighteen years after it was required by Congress.
Our meeting did not decide any of these issues. But as the consumer representative at the meeting, we were able to represent you and express these points strongly. With your help and that of Congress, especially the appropriations committee that controls FDA’s purse strings, we will finally win this battle, no matter how long it takes.
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The issues listed above are very good, reasonable and required I believe. As usual, most of the companies like mine, are desirous of the FDA doing its job to keep adulterated and misbranded products off the shelf as well as unfounded claims. We jsut need to teach FDA how to define such products and quit with the obvious Rx drug mfr lobby intent to wipe out the industry. It’s really gotten old over the last 30 years. FDA, grow up, put some mature individuals with the consumer needs at heart in charge here and above all, enforce the protection mandate you already have!! That would be great! Quit beinig a Rx pawn looking for the destruction of consumer safety, freedom of choice and employment opportunity. In short grow up and grow some sensibility, maturity and awareness.
It seems as though the FDA has something against supplements and that we continually have to fight this attitude.
It’s just not an attitude of helping us to be healthy. It’s an attitude of control.
Thanks for all you do.
Attention Ms. Deborah Ray:
I’ve Retinitis Pigmentosa and therefore cannot use prescription drugs to enhance sexual performance like normal men can do. Read fine print on Viagra, Cialis, etc. and you will find that they don’t recommend these drugs for people wtih RP.
I’ve found other ways through dietary supplements to increase performance. Thanks to Senator Richard Durbin, I no longer have access to Andro which was a good dietary supplement for me.
THE FDA IS DISCRIMINATING AGAINST THE HANDICAP WITH THEIR ANTI-DIETARY SUPPLEMENT POLICIES AS I’M LEGALLY BLIND WITH THE RP. My case can be used as an example to get the FDA to back off and maybe someone in the Senate like Senator Orrin Hatch should modify the 1974 “Handicap Act” to allow for my access to ALL existing dietary supplements without any restrictions from the FDA as I’m using other supplements to slow down the vision loss, i.e. 15,000 I.U. Vitamin A (palmitate).
I know that I can’t sue the FDA, HOWEVER, if Big Pharma (the group who is actually running the FDA), in particular the ones who makes and sells Viagra and Cialis may be sued IF they are made aware of the fact that I’ve improved my sex life with dietary supplements and they are warned to back off my access to dietary supplements since I can’t use their prescription drugs. I am retired and I have plenty of time to deal with a lawsuit, especially since they are discriminating against ME.
Ms. Ray, I’m just giving the Alliance other options that may work, especially if you feel like you’ve hit the wall. I’m asking you to keep me in mind, just in case you feel you’re not making adequate progress. Thank you for your service and your valuable time.
Great work. Hopefully you can include Spermine and Spermidine in your discussions. Known for over 400 years and essential for health cell development and found in most foods, this bioidentical formula seems to be a mystery to the FDA. What is most important is they get rid of the word they use for everything. That word is adult rated.
I would hope that the FDA would take heavy consideration into account for the concerns of the consumer, natural health advocates and Congress. We should not be denied access to any supplements due to ridiculous restrictions & rules not to mention the aftermath of loss of industry revenue & even more – the loss of American jobs.
I am however, glad to see that the FDA withdrew guidance & agreed to start over. I see more fairness given by allowing natural health & consumer activists to the table at these meetings. I am so glad to have their representation & hope that their input will make the difference in resolving the issues still of deep concern to all of us consumers.
Thank you.
I hope this signals progress and not just more stonewalling , the feds favorite tactic .
I am nearly 87 years of age, and healthy because I take no pharmaceuticals, but instead am prescribed vitamin/mineral/herbal supplements by my holistic M.D. based on the results of tests that determine the levels of nutrients and minerals in my body. My income is near poverty level, but I manage to purchase these, plus a diet of organic foods, which I eat twice daily. I am grateful for the nutrient industry and all those connected with it, and I spread the word to all with whom I am in contact. I am also an activist with regards to GMO opposition, as well as involved in a committee which establishes organic community gardens around my city, including one on which we are now in process of establishing at the independent living senior complex of nearly 500 apartments to provide healthy vegetables to the aged whose choice otherwise is WalMart.
What is the plan for pyridoxamine?
Are you asking for it to be available again to the public?
Otherwise, this has been great news!
Keep up the good work.
We will continue to heed the call.
Thanks for representing we consumers at the meeting and future meetings. I want easy access to the organic supplements that I need and do not want the restrictions or prohibitions earlier put forth by the FDA.
Just when some Drs. are finally realizing how important supplements are we have tofight the
Drug Companies who influence the FDA. Thank you for watching out for our health.
I depend on supplements a lot.
It sounds like the supplement industry is making progress but it has traitors within.
Senators Orrin Hatch (R-Utah), previously a friend of the entire supplement industry has introduced a bill to not only ban the prodution and sale of a wide variety of muscle-building supplements but also to make their mere posession a felony offense.
That long-expired bottle in the back of your freezer that had been legally purchased could mean long jail time for you or for a loved one.
Senator Hatch apparently has the support of supplement companies in his home state of Utah.
The bill contains a specific exception for herbal products even if they are similar in both chemical structure and physiological effect to the banned supplements.
Our industry has allowed the FDA and DEA to “divide and conquer”. Herbal producers in Utah are prepared to toss the producers of synthetics “under the bus”, perhaps to eliminate competition or perhaps as a sacrificial lamb in the hope that regulators will be satisfied.
Only fools would believe that the FDA and DEA can ever be satisfied!
When they come for the herbal producers as well, who would be left to come to their defense?
See : http://www.supplementcounsel.com/blog/the-new-designer-steroid-bill-and-you-questions-and-answers-with-rick-collins
Thank YOU for all you hard work!!!!!
The best thing the FDA can do to ensure safety to consumers is to dissolve that agency ASAP!
Stop the greed.
To deny a person the god given right to ingest a natural ingredient vs taking the chemically altered
equivalent is total and complete insanity–
That is the problem with GMO’s and now this —
I want and I along with others have the right to consume what we want period
Thank you. From the bottom of my gut.
The FDA has no argument with regard to supplements as it has, and continues to approve synthetic drugs, far more undertested and dangerous than the supplements they’d have us believe are potentially dangerous. The whole thing is about money and nothing more.
These so-called advocates are nothing but gangsters in high places.. I don’t care how fair they write their manifesto, it will always be abused and eventually used (by these same watchers) against us.. Keep me informed as to what these bottom feeders are trying to choke down our throats and I’ll keep signing my name on those petitions that will show them that we are watching their snake like attempts to put one over us just to profit them and their masters. All of them should be immediately fired and all perks taken away then let’s see how they fair with big pharma once they get sick and can’t afford prescription drugs. Pathetic wimps..
Thank you and congratulation for taking action with the FDA!
Thank you so much for your careful research and reporting. I only wish there were a way to warn more people about how bad this situation is and how the FDA is just a revolving door for the Washington people who want to destroy our food safety and promote the horrors of GMOs.
My state Rep, Mr. Michaud, responded to my earlier personalized form letter, provided by ANH-USA, with the biggest mess of double-talk I ever had to read. His bottom line was that supplements must be supervised. WHY? Free market has done a better–and safer–job until now than Pharma ever did with FDA “supervision”.
And the bottom line on the article above seems to be, “Our meeting did not decide any of these issues.”
FDA’s willingness to rewrite is no mystery–FDA had already agreed to that after Orrin Hatch, holder of part of FDA’s purse strings, leaned on FDA. But he didn’t back FDA off from turning the law upside down–all he managed to get was just a short time extension. FDA doesn’t at all mind a six months’ extension–for patented adult drugs to be studied on children (strictly to extend patents, not for FDA approval or pediatric use). It is clear that nothing has changed in the game plan to restrict Pharma’s only real competitor, the supplements industry. Look at Pyridoxamine–wiped out on the supplements front, sold now only through a Pharma version–and that tells the tale of what lies ahead. Wipe out supplements. In steps Pharma. Market monopoly. Buried among the rubble of the recent meeting is the fact that FDA has no right to re-interpret any laws passed by Congress–nor to set terms such as the despicable “1994” rule or what shall be considered Old vs New for supplements–at all. Because supplements are nutrients and therefore outside FDA’s area of control–or they were, the last two times Congress backed off FDA on its attempts to grab control over them–and why would FDA keep trying to grab control? Money, market monopoly, and only Pharma–which pays such exorbitant sums to FDA and thus to Government–will be left standing.
If FDA has its way–will anyone donate so I can flee the country? Supplements are the sole reason I am free of ischemia and angina, and out of a wheelchair, with no oxygen tank and no bypass surgery and able to spell ordinary words again. And not lying in bed all day from constant spine and joint pain. I don’t want to go back to that. Maybe everyone could send a dollar a vote to name the stray cat I just took in. Probably some of you think I am joking…
They don’t mind listening to us blow hot air. It didn’t change a thing, did it!
I am 71 years old and have been a vegetarian for 40 years. I make all my food from scratch, because most packaged or pre-made food has chemicals, dyes, additives, preservatives, GMO’s and other things I can’t even pronounce. I have taken vitamens and supplements for 40 years to
give me the benefit of the nutrition I may not be getting from my diet. I am very helthy for my age.
Before I became a vegetarian I took the time to study nutrition and learned that it was necessary to
supplement my diet with the proper vitamens, which have done, without any ill effects. In my opinion the FDA and those that want to regulate vitamens need to spend more time regulating the
drugs that kill more people than vitamens. In the past and even to this day, I have taken massive
doses of Vitamen C, Vitamen E,A and D for a week without harming myself.
I hope that my freedom to take vitamens in my future will not be jeopardized with unnecessary rules and regulations that could hinder my over all health.
Gentlemen:
It is a known fact and on public record that the FDA takes orders from the pharaceutical industry, since it depends moneywise on the pharmaceutical industry. Its obvious why the FDA does what it does; supplements hurt the “bottom line of the drug iindustry. THIS “FACT is outrageous to say the leleast and should be “exposed” Also the prestigious New England Journal of Medicines articles exposing the failure of the medical system and its “buddies” also be exposed! The media is controlled by the $$$ it gets from advertising that the drug companies use to sell their products especially CBS’s 60 minute program.
Slowly but surely our socalled democracy is eroding like the climate change that’s happening worldwide; denied by those who have the heads buried deeply in the sands of deceit!
Aware citizens must use every means at their disposal; our media system is controlled from top to bottom what remains so far is the internet; however politicians also work not for us but for the special interests, there are exceptions of course, some pols are honest if you can find them? The American citizen refused to give the nomination to the representative from Texas, he was “just too honest” he told the truth which most egos hate to hear! why? who knows people are a mystery to themselves as well as to others! They love to vote for the best liar since tthey lie to themselves constantly’ its called “being in denial” a very common traiit for egos in general!
Havent found one ego who did not lie,, perhaps honest ones do exist somewhere certainly not on our planet thats for sure!
We need honest representation for our country to function and exist; we dont have that now; that is so evident that a bonafide idiot would know that!
That is why our congress is loaded with bonafide idiots who dont care as long as their pockets are filled with the green stuff! A very sorry state, but then the Romans, Greeks, and all of the great powers of the past, went throuigh the “same process” they allowed their egos to get away “with murder” its no pun its the truth! They also depreciated their currency etc. we are on the same track of course, its just a question of time before we do two things at the same time, “implode and explode, a truly remarkable “feat” and we are all on the “front road” waiting to see it happen!
Power in the wrong hands in time of course, destroys civilizations, ours as said, is in the process of experiencing…
FDA should be renamed the Federal Death Administration or perhaps the Food and Drug Abomination. Any organization or person that prohibits the acquisition of naturally occurring substances which aid in healing and/or provide nutritional value should be rendered null and void… frankly speaking they are in my book. No jurisdiction. What a travesty of humanity we’ve let these organizations become. I’m sure there are some good people there but ill guided no doubt.
Bravo!!!!
Well done, thank you so much.
Doc Blake
Nice work!
But watch out for underhanded tricks, etc.! Get everything the FDA verbnally says it will do that is propitious in writing with signatures sworn under penalty of perjury! I am not joking! dc
FDA has a history of showing anti consumer bias. This prediliction to making small business suffer under unneccessary and abusive burdens echoes the FDA past practices.
The FDA should not be messing with natural substances at all. Most prescription medicines are very bad; there are many people in this country who react very badly even to small doses of just about all prescription medicines; I am one of those people. However, I can take natural supplements without severe reactions. There is already too much government control in this country for medicines and many other issues. Yet, products that you know will harm you are allowed to be given to people who don’t know better. I don’t go to the doctor often because I know that I will be worse off; I know that the drug companies, the law makers, and the FDA are all dipping out of the same under the table money pots; it is time for this to stop and be truly concerned with the welfare of the people in this country instead of payloa.
Awesome 🙂 Also, I have access to pyridoxamine…
I appreciate the work you are doing to protect our rights as citizens to manage our own health. I have been taking nutraceuticals for 30 years and have reversed health problems by judiciously evaluating and treating them through nutition, exercise and vitamins/herbals.
Thank you for raising the consciousness of all us about the threats to our health choice freedoms.
Thank you for the update. I was aware of the B6 debacle. Hope the people prevail this time not the profit ONLY Pharma and their puppet FDA and the Politicians who support these no commonsense policies.
Thank you for your ongoing work to monitor the FDA, protect the rights of consumers and the products we want and need. These issues can become so convoluted it boggles the mind but your explanations are clear and to the point so a “lay” person, like myself, can understand the issues. Keep up the good work!
It is amazing to me that the FDA has so much power to do evil in the guise of protecting. Often all that is being protected is the pockets of big pharma and the healthcare industry. To the FDA, please don’t take us for fools. We have THE RIGHT to care for ourselves the way we see best. Get out of our pocketbooks! Get out of our healthcare choices!
Thank you ANH for your tireless efforts to make sure we continue to be allowed to make informed healthy choices about our supplements, please keep up the good fight!
The FDA is best left out of the supplement business. They now allow many FDA approved drugs that are known to be toxic. I would rather be in control of what I put in my body.
Thank you so much ANH USA for always fighting for us when it comes to natural supplements and our right to take as we choose. As an avid supplement supporter, I appreciate all the work that organizations such as yours do to protect our rights. The FDA is such a joke. We all know that some members on the board of FDA, are the very people that invest in the pharmaceutical companies. Talk about being objective. Ha! They have no clue as to what supplements can do for good overall health. Its because of the supplements that I take daily, that I feel as good as I do. My husband is a chiropractic physician and practices extensive nutrition for overall wellness, so we truly realize the importance of what you do, since it affects our scope of practice. Its well documented that supplements over time do prevent diseases. Its because of the FDA constantly approving genetically modified products and foods and other known harmful ingredients that cause disease and illness.
Thank You, Maria
Thanks for your persistence and tolerance. Please keep up the good work, we need you to do combat with the FDA. In my opinion they don’t have our best interests unless it pads their pockets. They need a complete overhaul as far as i am concerned. Just because the drug companies don’t make huge profits on supplements is no reason to micro manage them. The drugs that do make the market are frought with bad reports, incomplete analyses etc. Go for it and may God bless your endeavors.
I would not trust them as far as I could throw them and that’s NOT far!!
I believe FDA’s only role should be to determine if a food or drug is safe to be consumed. If a process to manufacture the food/drug then makes it UNSAFE, then go from there. “Truth in advertiising”, so to speak, should be addressed by a completely separate branch of government. I question whether FDA is another sell-out group which panders to the highest bidder. I increasingly suspect the FDA is another government branch which is a tool for big money groups, and isn’t concerned enough for the rights and freedom of the consumer to judge how to meet needs and desires.
Thank you ANH for persistently and courageously fighting this cause.
Watch Out! When a govt agency charts a couse of action, an inconvenience like a grass roots campaign will not divert them from their “destroy America” mission. I DO think that this is their goal because its the only explanation that explains their behavior. The rewrite will not be significantly better. Stopping their excesses will now require permanent vigilence on everybody’s part.
Thank you so much for all your efforts on behalf of all of us consumers of Natural supplements. The loopholes the FDA tries to let pass is nothing less than criminal. With mounting pressure from Big Pharma it is clear the FDA is “in bed” with them, looking to protect THEM, & not the consumers/public that they are SUPPOSED to be advocating/protecting. The lies & the whitewash continue!
Thank you for being our watch dog, and if you need help with letters , emails or calls we will be more than happy to supply them,keep up the good FIGHT!!!
I haven’t had a common cold that lasted over two days since Linus Pauling published on Vitamin C in 1965. I take substantially more than the RDA, and tremor every time the FDA gets on a regulatory rampage. We should get rid of them and their revolving door with big pharma.
The FDA is the spokes person (lapdog) for “Big Pharma” ie. big drug companies intent on removing natural therapeutics from the American public. All the actions are a thinly veiled attempt to carry out their coup d’etat against the natural supplement industry. A cursory exam of their ( FDA’s) actions will demonstrate that fact.Herbs and the therapuetic use of dietary supplements are effective options for many conditions ; treated both at home and as office visits to conventional Western MD’S. MD’s recieve no training in their use and stand both naked and ineffectual in the attempt to both discredit then control the use of dietary supplements. Western medicine (not scientific investigation) and Big Pharma should be denied the opportunity to control the use of Traditional Medicines,herbals,vitamins ,etc.
As a general consumer of quality supplements from reputable sources, I applaud and strongly support all your efforts to keep these products from the NDI classification by the FDA. Speaking from my own personal experience, my health and overall condition have improved so significantly over the past 15 years that people now seek out my advice on how I stay so young. On a daily basis, I consume approximately 30 different supplements, all backed by significant research to show the value of each purported benefit. I track my energy level, my lean body mass, my mental acuity, my dexterity, and more. I am now in my mid-sixties with no need for any drugs that deliver so many negative long lasting side effects. I once had arthritec pains in many of my joints but no longer. Naturally, it takes more than supplementation for the complete transformation. You have heard it all before but it also requires a good diet of hormone free natural foods, strength training (not stressing
As a general consumer of quality supplements from reputable sources, I applaud and strongly support all your efforts to keep these products from the NDI classification by the FDA. Speaking from my own personal experience, my health and overall condition have improved so significantly over the past 15 years that people now seek out my advice on how I stay so young. On a daily basis, I consume approximately 30 different supplements, all backed by significant research to show the value of each purported benefit. I track my energy level, my lean body mass, my mental acuity, my dexterity, and more. I am now in my mid-sixties with no need for any drugs that deliver so many negative long lasting side effects. I once had arthritic pains in many of my joints but no longer. Naturally, it takes more than supplementation for the complete transformation. You have heard it all before but it also requires a good diet of hormone free natural foods, strength training, and hormone balancing. Doing it all is so easy now. It is so comforting knowing that I will not be a burden on the health care system or my family in life. Please keep up the good work.
I see the FDAs move as just another step toward implementing the codex alimentarius. We must be vigilant in stopping them from negating our access to quality foods and supplements. Thank you ANH-USA for all your good work.